Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Water Cultures Are More Sensitive Than Swab Cultures for the Detection of Environmental Legionella.

Water cultures were significantly more sensitive than concurrently collected swab cultures (n=2,147 each) in detecting Legionella pneumophila within a Veterans Affairs healthcare system. Sensitivity for water versus swab cultures was 90% versus 30% overall, 83% versus 48% during a nosocomial Legionnaires' disease outbreak, and 93% versus 22% post outbreak. Infect Control Hosp Epidemiol 2018;39:108-110.

Improving the Diagnosis of Legionella Pneumonia within a Healthcare System through a Systematic Consultation and Testing Program.

RATIONALE: Legionella testing is not recommended for all patients with pneumonia, but rather for particular patient subgroups. As a result, the overall incidence of Legionella pneumonia may be underestimated. OBJECTIVES: To determine the incidence of Legionella pneumonia in a veteran population in an endemic area after introduction of a systematic infectious diseases consultation and testing program. METHODS: In response to a 2011-2012 outbreak, the VA Pittsburgh Healthcare System mandated infectious diseases consultations and testing for Legionella by urine antigen and sputum culture in all patients with pneumonia. MEASUREMENTS AND MAIN RESULTS: Between January 2013 and December 2015, 1,579 cases of pneumonia were identified. The incidence of pneumonia was 788/100,000 veterans per year, including 352/100,000 veterans per year and 436/100,000 veterans per year with community-associated pneumonia (CAP) and health care-associated pneumonia, respectively. Ninety-eight percent of patients with suspected pneumonia were tested for Legionella by at least one method. Legionella accounted for 1% of pneumonia cases (n = 16), including 1.7% (12/706) and 0.6% (4/873) of CAP and health care-associated pneumonia, respectively. The yearly incidences of Legionella pneumonia and Legionella CAP were 7.99 and 5.99/100,000 veterans, respectively. The sensitivities of urine antigen and sputum culture were 81% and 60%, respectively; the specificity of urine antigen was >99.97%. Urine antigen testing and Legionella cultures increased by 65% and 330%, respectively, after introduction of our program. CONCLUSIONS: Systematic testing of veterans in an endemic area revealed a higher incidence of Legionella pneumonia and CAP than previously reported. Widespread urine antigen testing was not limited by false positivity.

Inflammatory Mediators and Clinical Outcome in Patients With Advanced Heart Failure Receiving Cardiac Resynchronization Therapy.

Expression of different cytokines and growth factors after myocardial injury has been associated with fibroplasia and dilatation versus reverse remodeling and myocardial repair. Specifically, the proinflammatory/fibrotic mediators: interleukin (IL)-6, epidermal growth factor, and fibroblast growth factor (FGF)-2 cause fibroplasia, whereas reparative cytokines including: IL-1α, IL-1ß, IL-4, and IL-13 can limit fibrosis. In appropriate patients, cardiac resynchronization therapy (CRT) reverses cardiomyopathy and improves outcome. However, a significant proportion will not respond to this therapy. We conducted this study to assess the association of proinflammatory/fibrotic and/or reparative immune response mediators at baseline with outcome after CRT. In the multicenter RISK study, plasma samples were collected prospectively before CRT implantation. Plasma IL-6, epidermal growth factor, FGF-2, IL-1α, IL-1ß, IL-4, and IL-13 were evaluated by Luminex technology. The primary outcome was predefined as freedom from heart failure hospitalization or death and a decrease in echocardiographic end-systolic volume of >15% at 12 months. To determine associations with the outcome, multivariate logistic regression models including baseline clinical characteristics and the specific cytokines and growth factors were constructed. On multivariate analysis of 257 patients, detectable reparative cytokine IL-13 was significantly associated with the primary outcome (odds ratio 3.79; 95% CI 2.10 to 6.82, p <0.0001). In contrast, detectable proinflammatory/fibrotic growth factor FGF-2 was negatively associated (odds ratio 0.31; 95% CI, 0.14 to 0.68; p = 0.004). In conclusion, in CRT recipients, baseline levels of inflammatory mediators affecting cardiac fibrosis versus repair were associated with subsequent clinical outcome.

The importance of clinical surveillance in detecting legionnaires' disease outbreaks: a large outbreak in a hospital with a Legionella disinfection system-Pennsylvania, 2011-2012.

BACKGROUND: Healthcare-associated Legionnaires' disease (LD) is a preventable pneumonia with a 30% case fatality rate. The Centers for Disease Control and Prevention guidelines recommend a high index of suspicion for the diagnosis of healthcare-associated LD. We characterized an outbreak and evaluated contributing factors in a hospital using copper-silver ionization for prevention of Legionella growth in water. METHODS: Through medical records review at a large, urban tertiary care hospital in November 2012, we identified patients diagnosed with LD during 2011-2012. Laboratory-confirmed cases were categorized as definite, probable, and not healthcare associated based on time spent in the hospital during the incubation period. We performed an environmental assessment of the hospital, including collection of samples for Legionella culture. Clinical and environmental isolates were compared by genotyping. Copper and silver ion concentrations were measured in 11 water samples. RESULTS: We identified 5 definite and 17 probable healthcare-associated LD cases; 6 case patients died. Of 25 locations (mostly potable water) where environmental samples were obtained for Legionella-specific culture, all but 2 showed Legionella growth; 11 isolates were identical to 3 clinical isolates by sequence-based typing. Mean copper and silver concentrations were at or above the manufacturer's recommended target for Legionella control. Despite this, all samples where copper and silver concentrations were tested showed Legionella growth. CONCLUSIONS: This outbreak was linked to the hospital's potable water system and highlights the importance of maintaining a high index of suspicion for healthcare-associated LD, even in the setting of a long-term disinfection program.

Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients.

BACKGROUND: We conducted a prospective multicenter study to assess the prognostic value of combined baseline preimplant plasma levels of the biomarkers cardiac troponin T (TnT) and B-type natriuretic peptide (BNP) among cardiac resynchronization therapy (CRT) with or without defibrillator capability (CRT-D) recipients. METHODS: At CRT-D implant, patients were stratified based on detectable TnT (≥0.01 ng/mL) and elevated BNP (predefined as >440 pg/mL) levels. Patients were classified into three groups: high (both detectable TnT and high BNP), intermediate (either detectable TnT or high BNP), or low (nondetectable TnT and low BNP). Patients were followed for 12 months. Survival curves free from mortality or heart failure hospitalizations (HFH) were assessed. To assess the predictive value of biomarker category, we constructed a multivariate Cox regression model, including the covariates of age, New York Heart Association class, left ventricular ejection fraction (LVEF), and QRS duration. RESULTS: A total of 267 patients (age 66 ± 12 years, males 80%, LVEF 25% ± 8%, ischemic cardiomyopathy 52%, QRSd 155 ± 26 ms) were studied. After 1 year, there were 13 deaths and 25 HFH events. A significant difference in event-free survival among the three groups was observed, with high and intermediate categories having worse survival than low (log-rank test, P < 0.001). In the multivariate model, risk category was a significant predictor of outcome: hazard ratios were 7.34 (95% confidence interval [CI]: 2.48-21.69) and 2.50 (95% confidence interval [CI]: 1.04-6.04) for high-risk and intermediate-risk groups, respectively (P < 0.0001). CONCLUSION: Among CRT-D recipients, baseline TnT and BNP values alone or in combination provide significant prognostic value for the outcome of mortality or HFH.

2-octyl-cyanoacrylate glue for fixation of STSG in genitourinary tissue defects due to Fournier gangrene: a preliminary trial.

BACKGROUND: In these reported cases, we observed the outcomes of skin take and wound healing using 2-octyl-cyanoacrylate glue, which was used as tissue glue in the reconstruction of complex genital skin loss due to fournier gangrene. METHODS: Fifteen patients with Fournier's gangrene were treated in this study. After initial surgical debridement, all defects were repaired using STSG. In this method a thin layer of 2-octyl-cyanoacrylate was dripped on the recipient site immediately before graft application. All wounds were followed up postoperatively and observed for evidence of graft take, seroma or hematoma formation, drainage, and infection. Patient and physician satisfaction were also determined. RESULTS: Grafts were completely accepted in all fifteen patients. None of the patients had wound infection, seroma, hematoma, or other complications. CONCLUSION: Use of 2-octyl-cyanoacrylate glue (Glueseal) for STSG fixation in complex genital skin defects after Fournier gangrene may be an acceptable alternative to conventional surgical closure with a good cosmetic outcome. Further studies are needed to confirm our initial success with this approach.

Impact of endoscopic versus open saphenous vein harvest technique on late coronary artery bypass grafting patient outcomes in the ROOBY (Randomized On/Off Bypass) Trial.

OBJECTIVE: In the Randomized On/Off Bypass (ROOBY) Trial, the efficacy of on-pump versus off-pump coronary artery bypass grafting was evaluated. This ROOBY Trial planned subanalysis compared the effects on postbypass patient clinical outcomes and graft patency of endoscopic vein harvesting and open vein harvesting. METHODS: From April 2003 to April 2007, the technique used for saphenous vein graft harvesting was recorded in 1471 cases. Of these, 894 patients (341 endoscopic harvest and 553 open harvest) also underwent coronary angiography 1 year after coronary artery bypass grafting. Univariate and multivariable analyses were used to compare patient outcomes in the endoscopic and open groups. RESULTS: Preoperative patient characteristics were statistically similar between the endoscopic and open groups. Endoscopic vein harvest was used in 38% of the cases. There were no significant differences in both short-term and 1-year composite outcomes between the endoscopic and open groups. For patients with 1-year catheterization follow-up (n=894), the saphenous vein graft patency rate for the endoscopic group was lower than that in the open harvest group (74.5% vs 85.2%, P<.0001), and the repeat revascularization rate was significantly higher (6.7% vs 3.4%, P<.05). Multivariable regression documented no interaction effect between endoscopic approach and off-pump treatment. CONCLUSIONS: In the ROOBY Trial, endoscopic vein harvest was associated with lower 1-year saphenous vein graft patency and higher 1-year revascularization rates, independent of the use of off-pump or on-pump cardiac surgical approach.

Frequency of major noncardiac surgery and subsequent adverse events in the year after drug-eluting stent placement results from the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry.

OBJECTIVES: This study sought to determine the frequency of noncardiac surgery and adverse post-operative events among patients who recently received a drug-eluting stent (DES) following noncardiac surgery. BACKGROUND: Little is known about frequency of and risks associated with noncardiac surgery after DES implantation. METHODS: In the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry, consecutive patients who underwent attempted stent placement at 42 hospitals between July 2004 and September 2005 were enrolled and followed for 1 year. In this study, we analyzed patients who received ≥ 1 DES to determine the frequency of noncardiac surgery and cardiac death, myocardial infarction, or stent thrombosis in the following week. RESULTS: Among 4,637 DES recipients, 206 (4.4%) underwent major noncardiac surgery in the following year (median days to surgery: 179 [interquartile range 112 to 266 days; range 13 to 360 days]). Overall, stent use averaged 1.5 per patient. The most frequent operations were orthopedic (36%), abdominal (31%), and vascular (20%). Compared with patients who did not undergo surgery, those who did were older, more likely to be women, and have had a prior stroke; the frequencies of prior myocardial infarction, prior coronary artery bypass graft, and diabetes were similar, as were left ventricular ejection fraction and indication for percutaneous coronary intervention. In the 7 days after surgery, 4 patients had a cardiac death, myocardial infarction, or stent thrombosis (1.9% [exact 95% confidence interval (CI): 0.5% to 4.9%]). The risk of the composite outcome was increased 27-fold in the week following noncardiac surgery compared with any other week after stent implantation (hazard ratio [HR]: 27.3 [95% CI: 10.0 to 74.2], p < 0.001). CONCLUSIONS: The frequency of major noncardiac surgery in the year after DES placement is >4%. Although the overall risk of adverse outcomes was less than previously reported when surgery is performed months after DES placement, it is significantly increased in the week after major noncardiac surgery.

Hypercholesterolemia paradox in relation to mortality in acute coronary syndrome.

BACKGROUND: Hypercholesterolemia is a risk factor for coronary artery disease, yet is associated with lower risk of adverse outcomes in patients with acute coronary syndromes (ACS). HYPOTHESIS: We explored this paradox in 84,429 patients with non-ST-segment elevation ACS in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines registry. METHODS: We examined the association between a history of hypercholesterolemia and in-hospital mortality after adjusting for clinical covariates. After excluding patients with previously diagnosed hypercholesterolemia, we repeated the analysis, examining the association between newly diagnosed hypercholesterolemia (in-hospital low-density lipoprotein cholesterol [LDL-C] > or = 100 mg/dL) and mortality. RESULTS: A history of hypercholesterolemia was associated with lower in-hospital mortality (unadjusted odds ratio [OR]: 0.58; 95% confidence interval [CI]: 0.55, 0.62). This protective association persisted after adjusting for baseline characteristics (OR: 0.71; 95% CI: 0.66, 0.76) and prior statin use (OR: 0.74; 95% CI: 0.68, 0.80). Among 22,711 patients with no history of hypercholesterolemia, 12,809 had a new in-hospital diagnosis of hypercholesterolemia. Unadjusted mortality in these patients was lower than among those with normal LDL levels (OR: 0.58; 95% CI: 0.50, 0.67); however, this difference was not significant after multivariable adjustment (OR: 0.86; 95% CI: 0.73, 1.01). CONCLUSIONS: The association of hypercholesterolemia with better outcomes highlights a major challenge in observational analyses. Our results suggest this paradox may result from confounding due to other clinical characteristics, impact of statin treatment, and perhaps most importantly, the fact that previously diagnosed hypercholesterolemia is a marker for patients with more prior medical contact.

Clinical significance of borderline elevated troponin I levels across different assays in patients with suspected acute coronary syndrome.

We aimed to elucidate the clinical significance of borderline troponin I (TnI) increases and see if such increases are of similar significance across different assays. Markedly increased TnI is a strong predictor of adverse cardiac events. It is not clear if borderline increases with different commercially available TnI assays provide similar prognostic information. From January 2001 to February 2004, 3 different TnI assays (Beckman Access TnI, Beckman Access AccuTnI, and Vitros ECI Troponin) were used to evaluate the peak TnI value in 1,152 consecutive patients admitted with suspected acute coronary syndrome/non-ST-elevation myocardial infarction (MI). Recommended cutoffs were used to differentiate borderline from marked increases reported as consistent with MI. Clinical data and 30-day death/new MIs were determined by chart abstraction. Demographics and cardiac risk factors were similar for the 3 groups. Frequency of borderline TnI ranged widely among assays (18.7% to 42.1%) but was significantly less with the Vitros ECI Troponin assay (p <0.0001). Prognostic significance of borderline increased TnI values also varied greatly by assay, with borderline Beckman Access AccuTnI increases being predictive of adverse 30-day outcomes (odds ratio 4.0, 95% confidence interval 1.46 to 10.97, p = 0.007), but not with the other 2 assays. Borderline increases were significantly associated with chronic renal insufficiency (CRI; serum creatine >1.5); the relation to adverse 30-day outcomes and borderline increases persisted after correcting for CRI in a multivariate logistic regression model. In conclusion, although borderline increased TnI levels are common and significantly associated with CRI, they do not all portend the same clinical prognosis. This study highlights the need for standardization of TnI levels across different assays.

Factors associated with the use of preventive care for contrast-induced acute kidney injury.

BACKGROUND: The factors that affect the implementation of preventive care for contrast-induced acute kidney injury (CIAKI) are unknown. OBJECTIVE: To assess patient and provider factors associated with the use of preventive care for CIAKI. DESIGN: Prospective cohort study. PARTICIPANTS: Patients with kidney disease undergoing procedures with intravascular iodinated radiocontrast. MEASUREMENTS: We recorded the use of preventive care defined as the administration of: (1) pre- and post-procedure isotonic intravenous (IV) fluid, (2) N-acetylcysteine, and (3) iso-osmolal radiocontrast. We surveyed patients' providers to assess their knowledge, experience, and training on CIAKI and used multiple logistic regression to assess the independent associations of patient and provider factors with the use of these preventive interventions. RESULTS: We enrolled 660 patients and 87 providers. Patient factors associated with use of IV fluid and N-acetylcysteine were higher baseline serum creatinine (OR 1.5 and 5.0, p < 0.05) and inpatient status (OR 3.0 and 6.3, p < 0.05), while higher baseline serum creatinine was associated with the use of iso-osmolal contrast (OR = 13.4, p < 0.01). The primary provider characteristics associated with the use of IV fluid and N-acetylcysteine were a greater degree of prior training on CIAKI (OR 1.9 and 2.8, p < 0.05) and higher number of prior patients with CIAKI (OR 2.7 and 2.6, p < 0.05). CONCLUSIONS: Patient baseline kidney function and provider training and experience with CIAKI are independently associated with the use of preventive care. Efforts to increase and intensify the training providers receive on CIAKI may help decrease the incidence of this costly iatrogenic condition.

Veterans' decision-making preferences and perceived involvement in care for chronic heart failure.

BACKGROUND: Patients with heart failure require a great deal of information about their disease, but it is also important to know about their preferences for involvement in medical decision making and about factors that may influence their preferences so that patients' needs, values, and preferences can be met by clinicians. OBJECTIVES: We assessed patients' preferred role and perceived level of involvement in medical decision making and tested the effects of patients' age and role preference on perceived involvement in medical decision making. METHODS: We conducted a telephone survey of 90 adults being treated for heart failure by a Veterans Affairs primary care provider or cardiologist. Patients' preferred role in treatment decisions was assessed using the Control Preferences Scale. Perceptions about their involvement in decision making during the most recent clinic visit was measured using a subscale of the Perceived Involvement in Care Scale. Descriptive, correlational, and generalized linear regression analyses were conducted. RESULTS: Most patients were elderly (mean = 70.1 years), male (94.4%), and white (85.6%), and had New York Heart Association class II disease (55.6%). Forty-three patients (47.8%) preferred a passive role in decision making, 19 patients (21.1%) preferred an active role, and 28 patients (31.1%) preferred a collaborative role. Most patients believed that their decision-making involvement was relatively passive, as indicated by a mean score of .96 (range, 0-4) on the Perceived Involvement in Care Scale decision-making subscale. Older age was associated with passive role preference (r = .263; P < .05) and less perceived involvement in decision making (r = -.279; P < .01). In addition, less perceived involvement in decision making during the last clinic visit was associated with a preference for a more passive decision-making role (r = rho.355; P < .01). Generalized linear regression analysis indicated that when patients' perceived decision-making involvement was regressed on age and patients' role preferences, age was no longer significantly associated with involvement (beta = -.196; P = .061), but that control preferences continued to exhibit an independent effect on perceived involvement in medical decision making (beta = -.341; P = .003). CONCLUSION: The results suggest that the preferences of patients with heart failure for a more passive role in decision making may be a stronger independent predictor of patients' perceived involvement in decision making than patients' age.

"They diagnosed bad heart": a qualitative exploration of patients' knowledge about and experiences with heart failure.

BACKGROUND: Patient education is central to the management of individuals with heart failure; therefore, it is important to know what these patients understand and experience both clinically and personally. OBJECTIVES: This study qualitatively explored patients' knowledge regarding a heart failure diagnosis, their understanding of their cardiac care providers' treatment recommendations, and their views concerning the impact of heart failure on their daily lives and prognosis. METHODS: A qualitative study was conducted whereby data were collected through 25 telephone interviews with adults being followed for heart failure at a Veterans Affairs medical center. Subjects were interviewed using semistructured open-ended questions. Audiotaped responses were analyzed using grounded theory methods. RESULTS: The majority of participants were elderly, male, and white, and had New York Heart Association class II disease. Participants without angina typically experienced a lengthy and difficult diagnostic delay, with symptoms misattributed to comorbid diseases. Most understood the importance of self-monitoring and adhering to physician recommendations, and their discussions of life-changing effects typically focused on loss of physical functioning and decreased quality of life. Although participants wanted to know their prognosis, most had not received information about it or about advance care planning. CONCLUSION: Patients require opportunities for enhanced communication with physicians and health care team members during the challenging diagnostic period and subsequently need more information about their medical condition and prognosis.

Prevention, incidence, and outcomes of contrast-induced acute kidney injury.

BACKGROUND: Little is known about whether health care providers (physicians) implement preventive care for contrast-induced acute kidney injury (CIAKI). The objectives of our prospective cohort study were (1) to assess provider use of preventive strategies for CIAKI, (2) to determine the incidence of CIAKI, and (3) to examine the association of CIAKI with adverse outcomes at 30 days, including death, need for dialysis, and hospital admission. METHODS: We prospectively identified patients with estimated glomerular filtration rates less than 60 mL/min/1.73 m(2) undergoing procedures with intravascular radiocontrast agents and recorded the use of intravenous fluids and N-acetylcysteine and the discontinuation of nonsteroidal anti-inflammatory medications. We measured postprocedure serum creatinine levels to quantify the incidence of CIAKI and tracked 30-day mortality and need for dialysis or hospitalization to evaluate the association of CIAKI with these outcomes. RESULTS: Preprocedure and postprocedure intravenous fluids were administered to 264 of 660 study patients (40.0%), more commonly with coronary angiography than with computed tomography (91.2% vs 16.6%, P < .001). N-acetylcysteine was administered to 39.2% of patients, while only 6.8% of patients using nonsteroidal anti-inflammatory drugs were instructed to discontinue the medication. In a propensity analysis, the use of intravenous fluids was associated with a reduced rate of CIAKI. The incidence of CIAKI was lowest following computed tomography (range, 0.0%-10.9%) and was highest following noncoronary angiography (range, 1.9%-34.0%). Eleven patients (1.7%) died, 1 patient (0.2%) required dialysis, and 83 patients (12.6%) were hospitalized; however, CIAKI was not independently associated with hospital admission or death. CONCLUSIONS: Strategies to prevent CIAKI are implemented nonuniformly. Although biochemical evidence of CIAKI is relatively common, clinically significant CIAKI is rare. These findings should help health care providers focus the use of preventive care on the highest-risk patients and have important implications for future clinical trials.

The incidence of clinically significant contrast-induced nephropathy following non-emergent coronary angiography.

OBJECTIVES: The primary aim of this study was to assess the incidence of clinically significant contrast-induced nephropathy (CIN) among patients undergoing non-emergent coronary angiography. BACKGROUND: Although retrospective analyses have emphasized the association of CIN with adverse patient outcomes, the actual incidence of clinically significant CIN following non-emergent coronary angiography is not clear. METHODS: We prospectively identified patients with baseline estimated glomerular filtration rates (eGFR) < 60 ml/min/1.73 m(2) undergoing non-emergent coronary angiography. We measured serum creatinine 48-96 hr following angiography and assessed the incidence of CIN using two definitions, a rise in Scr > or = 25% and > or = 0.5 mg/dl. We tracked the need for dialysis, hospitalization related to kidney injury, and 30-day mortality to examine the association of CIN with these outcomes. RESULTS: We enrolled 181 patients with a median eGFR of 52 ml/min/1.73 m(2). Of the 165 patients (91%) with post-procedure Scr data, the incidence of CIN was 6.1-8.5%. One patient required dialysis (0.55%) and one (0.55%) died within 30 days. Although 38 patients required hospital admission, CIN was not associated with the need for hospitalization. Patients with an increase in Scr > or = 25% demonstrated a trend toward increased risk for 30-day mortality (P = 0.09), whereas those with increments in Scr > or = 0.5 mg/dl had a marginally higher risk for dialysis (P = 0.06) and 30-day mortality (P = 0.06), although these associations failed to meet the level of statistical significance. CONCLUSIONS: Biochemically defined CIN occurs in a small, but notable proportion of patients undergoing non-emergent coronary angiography. However, clinically significant CIN is very uncommon.

Comparison of frequency of new-onset atrial fibrillation or flutter in patients on statins versus not on statins presenting with suspected acute coronary syndrome.

The effect of statins on the incidence of new-onset atrial fibrillation (AF) in patients presenting with suspicion of acute coronary syndrome (ACS) is unknown. Our study population consisted of patients admitted to a tertiary care Veterans Administration hospital with suspicion of ACS between November 2001 and January 2006. All patients had an electrocardiogram on admission that was compared with a previous electrocardiogram to confirm new-onset AF or atrial flutter. Of 1,526 patients, 164 (10.8%) had new-onset AF and 601 (39.4%) were on a statin on admission. Patients with AF were significantly more likely to be older, Caucasian, have renal insufficiency and anemia, and less likely to be diabetic, on a statin or angiotensin-converting enzyme inhibitor on admission, or have chest pain as a presenting complaint. In univariate analysis, patients on statins were significantly less likely to have new-onset AF (odds ratio 0.40, 95% confidence interval 0.33 to 0.69, p <0.01). This relation persisted in the multivariate model (odds ratio 0.57, 95% confidence interval 0.39 to 0.83, p <0.01) after correcting for age, race, diabetes mellitus, chest pain, and use of angiotensin-converting enzyme inhibitor. In conclusion, patients presenting with suspicion of ACS were much less likely to have newonset AF if they were on a statin at time of presentation.

Effect of hyponatremia (<135 mEq/L) on outcome in patients with non-ST-elevation acute coronary syndrome.

Hyponatremia is associated with adverse outcomes in patients with heart failure and ST-elevation myocardial infarction (STEMI). We evaluated the effect of hyponatremia on outcomes in patients with suspected acute coronary syndrome and non-STEMI. All patients had a sodium level determined at time of admission, at 24 and 48 hours, and at discharge. Of 1,478 patients, 341 (23.1%) were hyponatremic (sodium <135 mEq/L) on presentation. Patients who had hyponatremia on admission were significantly more likely to die or have recurrent myocardial infarction in the next 30 days (odds ratio 1.98, 95% confidence interval 1.35 to 2.89, p <0.001). This relation persisted after adjusting for factors such as age, left ventricular ejection fraction, use of diuretics before admission, hypotension on presentation, anemia, chronic renal insufficiency, pulmonary edema, and high troponin levels (odds ratio 1.7, 95% confidence interval 1.1 to 2.5, p = 0.01). In conclusion, hyponatremia on admission is associated with 30-day adverse outcome in patients presenting with suspected acute coronary syndrome/non-STEMI.

Detectable troponin levels predict poor prognosis in patients with left ventricular dysfunction undergoing internal defibrillator implantation.

INTRODUCTION: Troponin levels have been demonstrated to predict mortality in patients with cardiomyopathy. Implantable cardiac defibrillator (ICD) devices have been demonstrated to improve survival. It is not clear if ICDs would mitigate the negative outcome predicted by elevated troponin levels. METHODS: We collected baseline blood samples for troponin T (TnT) and creatinine kinase-MB fraction in consecutive patients immediately before successful pectoral transvenous ICD implant. Patients were followed for total mortality. For analysis, patients were grouped by TnT detectability (>or=0.01 ng/mL). RESULTS: Fifty-two men, aged 68 +/- 10 years, were studied. Mean ejection fraction was 29 +/- 12% and 65% had ischemic cardiomyopathy. Follow-up duration was 17 +/- 8 months. None of the patients had abnormal creatinine kinase-MB fraction levels (1.7 +/- 1.1 ng/mL). There were 37 patients with no detectable TnT (Group I) and 15 with detectable TnT (Group II). There was no difference between the two groups in terms of age (68 vs 69, P = NS), ejection fraction (30 vs 29%, P = NS), or proportion of patients with ischemic cardiomyopathy (68 vs 60%, P = NS). During follow-up 16 (31%) patients died. Patients in group I had mortality of 16% (6/37) compared to 67% mortality (10/15, P < 0.001) in group II. On multivariate analysis, detectable TnT remained an independent predictor of mortality (HR 4.5, CI 1.4-14.25, P = 0.01). CONCLUSION: In a cohort of patients with cardiomyopathy undergoing ICD implantation for standard clinical indications, presence of detectable TnT was associated with high mortality despite ICD implantation. TnT obtained before ICD implantation may be useful for risk stratification.